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Expert Rev Gastroenterol Hepatol

Following the end of that development program, AOD9604 received a GRAS (Generally Recognized As Safe) designation from the FDA for use as a food ingredient a regulatory category that is separate from, and does not equate to, approval as a pharmaceutical drug

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The authors thank Marie Fleisner of the Marshfield Clinic Research Foundations Office of Scientific Writing and Publication for editorial support in the preparation of this manuscript